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NCT07784270PHASE3Recruiting

A Study to Evaluate Effect of AZD6234 in Adult Participants With Type 2 Diabetes Mellitus and Obesity or Overweight

AstraZeneca

Start Date

8/20/2026

Completion Date

8/8/2028

Summary

The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment

Detailed Description

This is a Phase III, global, randomized, parallel-group, double-blind, multicentre study to assess the efficacy and safety of AZD6234 compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM) and obesity or overweight. Eligible participants will be randomized to either receive AZD6234 or matching placebo respectively.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Males \& females (inclusive of all gender identities) age ≥18 years * BMI ≥27 kg/m2 * Diagnosed with T2DM ≥90 days prior to Screening * HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤10% (86 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent (as per local labelling) * Stable body weight (≤5% body weight change) for at least 3 months prior to Randomisation * History of at least one self-reported unsuccessful attempt to lose body weight in lifetime Exclusion Criteria: * Obesity primarily caused by other endocrine disorders * Type 1 diabetes mellitus (or any other diabetes mellitus that is not clearly Type 2 diabetes), OR have history of ketoacidosis or hyperosmolar coma/state within 3 months prior to Screening * Significant hepatobiliary disease and/or any of the following results at Screening: * ALT ≥ 3.0 X ULN * AST ≥ 3.0 X ULN * TBL \> 1.5 X ULN (except for cases of known Gilbert's Syndrome) * Has received treatment with a GLP-1 receptor agonist or GLP-1 containing medication for any indication within 3 months before Randomisation * Use of insulin therapy for T2DM within 3 months prior to screening

Interventions

DRUG

AZD6234

DRUG

Placebo

Interested in This Trial?

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Conditions

Obesity or OverweightDiabetes Mellitus, Type 2

Locations

Research Site

Fairhope, Alabama 36532

United States

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Huntsville, Alabama 35801

United States

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Mobile, Alabama 36608

United States

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Mesa, Arizona 85213

United States

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Phoenix, Arizona 85044

United States

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Tucson, Arizona 85715

United States

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Little Rock, Arkansas 72205

United States

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Bakersfield, California 93309

United States

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Gardena, California 90247

United States

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Lincoln, California 95648

United States

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Torrance, California 90503

United States

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Walnut Creek, California 94598

United States

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Coral Gables, Florida 33134

United States

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Fleming Island, Florida 32003

United States

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Fort Lauderdale, Florida 33316

United States

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Ocoee, Florida 34761

United States

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Woodstock, Georgia 30189

United States

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Chicago, Illinois 60640

United States

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Melrose Park, Illinois 60160

United States

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Lenexa, Kansas 66219

United States

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Newton, Kansas 67114

United States

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Monroe, Louisiana 71201

United States

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Beltsville, Maryland 20705

United States

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Lanham, Maryland 20706

United States

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Oxon Hill, Maryland 20745

United States

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Rockville, Maryland 20852

United States

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North Dartmouth, Massachusetts 02747

United States

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Farmington Hills, Michigan 48336

United States

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Fayette, Mississippi 39069

United States

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Kansas City, Missouri 64111

United States

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Kansas City, Missouri 64114

United States

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St Louis, Missouri 63141

United States

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Omaha, Nebraska 68114

United States

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Omaha, Nebraska 68144

United States

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Eatontown, New Jersey 07724

United States

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Somerset, New Jersey 08873

United States

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Warren Township, New Jersey 07059

United States

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Greensboro, North Carolina 27408

United States

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Monroe, North Carolina 28112

United States

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Kent, Ohio 44240

United States

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Scottdale, Pennsylvania 15683

United States

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Franklin, Tennessee 37067

United States

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Jackson, Tennessee 38305

United States

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Knoxville, Tennessee 37938

United States

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DeSoto, Texas 75115

United States

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El Paso, Texas 79935

United States

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Houston, Texas 77099

United States

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Midland, Texas 79707

United States

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Pasadena, Texas 77504

United States

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San Antonio, Texas 78207

United States

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San Antonio, Texas 78215

United States

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San Antonio, Texas 78251

United States

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Manassas, Virginia 20110

United States

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Norfolk, Virginia 23504

United States

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Buenos Aires, C1120AAC

Argentina

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CABA, C1425HFA

Argentina

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Ciudad de Buenos Aires, C1094AAD

Argentina

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Mendoza, 5500

Argentina

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Ramos Mejía, B1704ETD

Argentina

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Rosario, S2000PBJ

Argentina

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San Nicolás, B2900DMH

Argentina

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Botany, 2019

Australia

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Camberwell, 3124

Australia

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Charlestown, 2290

Australia

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Helensvale, 4212

Australia

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Maroubra, 2035

Australia

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Waitara, 2077

Australia

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Calgary, Alberta T3R 1W9

Canada

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Vancouver, British Columbia V5Y 3W2

Canada

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Moncton, New Brunswick E1G 1A7

Canada

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Truro, Nova Scotia B2N 1L2

Canada

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Hamilton, Ontario L8L 5G8

Canada

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Markham, Ontario L3S 0A2

Canada

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North York, Ontario M6B 3H7

Canada

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Sarnia, Ontario N7T 4X3

Canada

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Scarborough Village, Ontario M1R 0B1

Canada

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Stoney Creek, Ontario L8J 3W2

Canada

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Stouffville, Ontario L4A1H2

Canada

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Toronto, Ontario M4G3E8

Canada

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Toronto, Ontario M6G 1M2

Canada

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Joliette, Quebec J6E 6A9

Canada

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Montreal, Quebec H4J 1E3

Canada

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Montreal, Quebec H4N 2W2

Canada

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Québec, Quebec G2J 0C4

Canada

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Trois-Rivières, Quebec G9A 4P3

Canada

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Concepción, 4070060

Chile

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Concepción, 4070196

Chile

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Concepción, 4070566

Chile

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Iquique, 1111442

Chile

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Providencia, 7500504

Chile

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Santiago, 7510187

Chile

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Santiago, 7691236

Chile

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Santiago, 8331143

Chile

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Santiago,

Chile

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Beijing, 100050

China

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Cangzhou, 061001

China

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Changchun, 130011

China

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Chengdu, 610021

China

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Chengdu, 610072

China

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Danyang, 212399

China

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Ganzhou, 341000

China

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Guangzhou, 510280

China

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Huizhou, 516002

China

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Huzhou, 313003

China

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Lanzhou, 730000

China

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Nanjing, 210008

China

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Nanjing, 210009

China

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Panjin, 124009

China

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Suzhou, 215006

China

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Xianyang, 712000

China

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Berlin, 10117

Germany

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Berlin, 10629

Germany

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Bochum, 44789

Germany

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Bünde, 32257

Germany

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Dresden, 01069

Germany

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Frankfurt, 60590

Germany

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Frankfurt, 60596

Germany

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Freiburg im Breisgau, 79106

Germany

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Göttingen, 37075

Germany

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Hamburg, 20095

Germany

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Hamburg, 20253

Germany

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Hanover, 30159

Germany

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Homburg, 66421

Germany

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Jerichow, 39319

Germany

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Karlsruhe, 76137

Germany

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Leipzig, 04177

Germany

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Magdeburg, 39110

Germany

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Mainz, 55128

Germany

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München, 80339

Germany

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Offenbach, 63065

Germany

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Balatonfüred, 8230

Hungary

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Budapest, 1024

Hungary

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Budapest, 1036

Hungary

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Budapest, 1132

Hungary

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Budapest, 1138

Hungary

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Debrecen, 4031

Hungary

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Debrecen, 4032

Hungary

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Miskolc, 3530

Hungary

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Nyíregyháza-Sóstóhegy, 4481

Hungary

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Szeged, 6725

Hungary

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Szolnok, 5000

Hungary

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Bangalore, 560092

India

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Indore, 452010

India

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Kolkata, 700014

India

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Nagpur, 440010

India

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Pune, 411021

India

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Pune, 411057

India

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Siliguri, 734012

India

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Visakhapatnam, 530002

India

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Aira, 899-5421

Japan

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Chūōku, 1040031

Japan

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Fukuoka, 814-0153

Japan

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Hachioji-shi, 192-0071

Japan

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Izunokuni-shi, 410-2295

Japan

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Kumamoto, 860-0833

Japan

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Nagoya, 451-8511

Japan

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Nagoya, 467-0806

Japan

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Nerima-ku, 177-0051

Japan

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Osaka, 537-0014

Japan

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Osaka, 540-0006

Japan

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Saga, 840-8571

Japan

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Sapporo, 060-0001

Japan

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Shinjuku-ku, 160-0008

Japan

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Suita-shi, 565-0853

Japan

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Tanabe-shi, 646-8558

Japan

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Bialystok, 15-481

Poland

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Elblag, 82-300

Poland

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Gdynia, 81-338

Poland

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Katowice, 40-081

Poland

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Katowice, 40-772

Poland

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Krakow, 30-105

Poland

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Krakow, 31-271

Poland

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Legnica, 59-220

Poland

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Lodz, 90-132

Poland

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Lodz, 90-338

Poland

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Poznan, 60-354

Poland

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Radzionków, 41-922

Poland

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Warsaw, 00-719

Poland

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Warsaw, 03-291

Poland

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Wroclaw, 53-673

Poland

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Bratislava, 831 03

Slovakia

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Bratislava, 83101

Slovakia

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Bratislava, 83106

Slovakia

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Košice, 040 01

Slovakia

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Košice, 04022

Slovakia

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Lučenec, 984 01

Slovakia

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Námestovo, 02901

Slovakia

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Prievidza, 97101

Slovakia

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Rožňava, 048 01

Slovakia

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Trebišov, 075 01

Slovakia

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Busan, 48108

South Korea

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Daegu, 42601

South Korea

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Daejeon, 35233

South Korea

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Incheon, 403-720

South Korea

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Seoul, 01830

South Korea

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Seoul, 06351

South Korea

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Seoul, 08308

South Korea

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Seoul, 143729

South Korea

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Seoul, 150-713

South Korea

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Suwon, 16247

South Korea

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A Coruña, 15006

Spain

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Alzira, 46600

Spain

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Barcelona, 08035

Spain

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Ferrol, 15405

Spain

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Lleida, 25198

Spain

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Málaga, 29010

Spain

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Oviedo, 33011

Spain

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Segovia, 40002

Spain

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Seville, 41010

Spain

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Seville, 41950

Spain

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Changhua, 500

Taiwan

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Kaohsiung City, 80756

Taiwan

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Taichung, 402

Taiwan

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Taichung, 404

Taiwan

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Taichung, 407219

Taiwan

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Taichung, 433004

Taiwan

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Tainan, 704

Taiwan

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Tainan, 710

Taiwan

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Taipei, 10002

Taiwan

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Taipei, 11490

Taiwan

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Zhubei, 302

Taiwan

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Chippenham, SN15 2SB

United Kingdom

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Corby, NN17 2UR

United Kingdom

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Corby, NN18 9EZ

United Kingdom

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Dunfermline, KY12 0SU

United Kingdom

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Hull, HU3 2PA

United Kingdom

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Northwood, HA6 2RN

United Kingdom